Prelude to a Mandatory Food Recall – and Suspension of Registration?

The Notification of Opportunity to Initiate a Voluntary Recall that FDA recently issued to a pet treat manufacturer gives a good indication of the type of evidence and circumstances that can prompt the agency to exercise its new mandatory recall authority. Before mandating a recall under FDCA section 423, FDA must first determine that there is a reasonable probability that the food is adulterated under section 402 or misbranded under section 403(w) and that use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. FDA must then give the manufacturer the opportunity to initiate a voluntary recall.

In this instance, FDA determined that the food in question was adulterated under section 402(a)(1), in that the food was contaminated with Salmonella, and also adulterated under section 402(a)(4), in that the food was manufactured under insanitary conditions whereby it may have been contaminated with Salmonella. FDA relied on testing of finished products conducted by the State of Colorado’s Department of Agriculture that purportedly showed the presence of Salmonella. Those products were collected at the manufacturing facility and also off the shelves at leading retailers. FDA also relied on its own testing of finished products, and of environmental testing that purportedly showed contamination of food contact surfaces. FDA made heavy use of genetic analysis to draw links between Salmonella-positive samples from different products manufactured at different times, and also between products and environmental swabs. In addition, FDA relied on evidence of insanitary conditions allegedly observed throughout the facility.

In a hint at potentially worse consequences, FDA’s Notification stated: “Your facility created, caused or was otherwise responsible for this reasonable probability of adulteration under section 402” – the standard for the suspension of a facility’s registration under section 415.